Senior Regulatory Affairs Officer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba-- our blood bank reagents portfolio-- and MosaiQ®-- one of the first multiplexing and multimodality automated testing platforms--are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

**SENIOR REGULATORY AFFAIRS OFFICER**

AliveDx are recruiting for a Senior Regulatory Affairs Officer to join the Regulatory Affairs team. The purpose of the role is building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide. In addition, the role will ensure that post-market surveillance and vigilance reporting obligations are met and will maintain the post-market surveillance and vigilance processes.

The role is a full-time, permanent position working 37.5 hours per week. This is to be based in our ARC office near Edinburgh, EH26 0BF.

**YOUR MISSION**

Your main responsibilities will include:

- Maintaining regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance and associated reporting, regulatory and standard watch.
- Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) - Part 1 and other country requirements as appropriate.
- Ensuring Post-market surveillance obligations are met and maintaining the post-market surveillance process.
- Leading and coordinating the vigilance process in interface with the complaint handling process.
- Ensuring Vigilance reporting obligations are met, i.e. interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (Biological Products Deviation Reports).
- Responsibility for providing guidance to the company on regulatory requirements and aspects.
- Providing support to the Department Leader of Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.
- Developing product labelling regulatory requirements for AliveDx products and for customer contracted products including but not limited to package labels, product labels and instructions for use.

**YOUR COMPETENCIES**
- A relevant degree and/or relevant work experience in a regulatory affairs environment.
- Experience in a medical device / IVD / biotech industry
- Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, BPDR, MEDDEV 2.12, etc.)
- Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities.
- Experienced in meeting with, making presentations to, and negotiating with regulators.
- Ability to prepare coherent regulatory reports and filings.

**WHAT WE OFFER**
- A highly dynamic and growing environment.
- An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
- A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.